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Validation Engineer

Spoločnosť: Unomedical s.r.o.
Miesto výkonu práce: Michalovce
Základná zložka mzdy (v hrubom): 950 € za mesiac
Dátum nástupu: ihneď
Dátum pridania ponuky: 08.11.2022
Dátum poslednej aktualizácie: 05.01.2023
Dátum platnosti ponuky: 05.03.2023
Pracovný a mimopracovný pomer: pracovný pomer na určitú dobu počet mesiacov: 12
Pracovná oblasť: Strojárstvo (vrátane výroby motorových vozidiel)
ISTP

Údaje o pracovnom mieste

Náplň (druh) práce

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE: CTEC) and in 2021 revenues were over $2 billion. To learn more about Convatec, please visit http://www.convatecgroup.com


Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us as a Validation Engineer, and you’ll drive progress that really means something.


About the role:
Position is supposed to cover validation of manufacturing processes in manufacturing units to be performed on time and in compliance with standards.
This is one of the key positions for realizing the first production and products of good quality and to the specification within defined frame of set ups.

Your key duties and responsibilities as a Validation Engineer:
• Validation of new production processes (except IQ) covering packaging, welding process, extrusion, catheter assembly process and if there are some additional process in the manufacturing unit in entire scope or partial scope as decided by agreement, however all processes have to be covered
• Cooperation with all others department to ensure smooth validation process in order to be aligned with time plan and regulations
• Re-validation of the processes as per time plan
• Validation of processes required to be validated as result of operational project
• Ensure availability of all necessary procedures, instructions, and forms according the rules and requirements and their compliance through validation/revalidation of the processes in manufacturing unit
• Author for Validation Protocols and Reports
• Development of new validation methods
• Updating and creating machine cards
• To conduct/support a process investigation, to recognize the inputs and outputs to the process by using a structured approach and tools such as process map, risk assessments, e.g. FMEA, Ishikawa diagram, flow charts
• To process and understand statistical data
• Contributing to shop floor ‘events’ and problem solving activities if required related to the processes
• Providing regular updates to relevant manager
• Providing validation and process knowledge & expertise if required

Požadované vzdelanie

Vysokoškolské vzdelanie prvého stupňa

Vysokoškolské vzdelanie druhého stupňa

Cudzie jazyky

anglický - pokročilá: B1 a B2

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